Clinical Research Director

5 days ago


Newport Beach, California, United States Medix™ Full time

Clinical Research Opportunity

We are seeking a skilled Clinical Research Coordinator to join our team at Medix™. This is an exciting opportunity to work on a 10-month contract, with a potential for extension.

About the Role:

The successful candidate will be responsible for coordinating clinical research protocols from study start-up to close-out. They will work closely with our research staff to collect, store, and maintain data in accordance with FDA regulations, International Council of Harmonization, and Good Clinical Practices.

Key Responsibilities:

  • Coordinate studies from start-up to close-out, ensuring compliance with regulatory requirements;
  • Collaborate with research staff to collect, verify, and record clinical information and data in electronic data capture systems (EDC);
  • Abstract data from necessary sources to complete EDC and resolve queries;
  • Perform EDC tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation, and safety coding;
  • May be responsible for regulatory submissions, including working knowledge of essential documents and IRB requirements;
  • Participate in site feasibility determination, site qualification visits, site initiation visits, and research-related meetings;
  • Recruit clinical trials to site;
  • Resolve queries;

Requirements:

  • 1+ years of experience as a CRC within the Ophthalmology space; if no experience with Ophthalmology, then 3+ years as a CRC is a must-have;
  • Education: Bachelor's degree in a related field or equivalent experience;
  • Schedule/Shift: 40 hours per week, Monday-Friday, 8AM-5PM;
  • Assignment Duration: 10-month contract, with potential for extension;

Salary and Benefits:

  • Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances);
  • Health Benefits / Dental / Vision (Medix offers 6 different health plans);
  • 401k (eligible after 6 consecutive months on assignment);
  • Short Term Disability Insurance;
  • Term Life Insurance Plan;

Additional Information:

MEDIX IS AN EQUAL OPPORTUNITY EMPLOYER. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable federal, state, and local laws.



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